Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients
None.

6.2     Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
Reconstituted solution
The reconstituted solution is physically-chemically stable for 24 hours at 25ºC.

6.4     Special precautions for storage

Keep the vial in the outer carton, in order to protect from light. Store below 25°C.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Colourless type II glass vial with butyl rubber stopper containing 1.5 g powder for reconstitution in 50 ml of drinking water.

Pack sizes: 1, 2 and 10 vials.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
The oral solution is prepared by dissolving the amount of powder of one vial in 50 ml of drinking water. One vial of Gliolan reconstituted in 50 ml of drinking water corresponds to a total dose of 1500 mg 5-aminolevulinic acid hydrochloride (5-ALA HCl).

The reconstituted solution is a clear and colourless to slightly yellowish fluid.

Gliolan is for single use only and any content remaining after first use must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.